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AzTrials

Systemic Lupus Erythematosus (SLE)Phase 2NCT04451772

A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State

A Phase 2 study testing Elsubrutinib and Upadacitinib in people with Systemic Lupus Erythematosus (SLE), run by AbbVie at 87 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus (SLE)
What is being tested?
Elsubrutinib and Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
185 participants
Where
87 sitesin 18 countries
Study dates
27 Jul 2020to 3 Jan 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib, upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination or matching placebo) and will not have developed any laboratory or clinical discontinuation criteria as defined in that study.
  • On stable background treatment for SLE throughout the study.

Who cannot join

  • Active, chronic, or recurrent viral, or bacterial infection.
  • Active tuberculosis (TB)
  • History of gastrointestinal (GI) perforation, diverticulitis, or a significantly increased risk for GI perforation per investigator assessment.
  • Participant require vaccination with live vaccine during study participation.

Trial locations and contacts

87 sites in 18 countries.

87 sites in 18 countries

United States21 sites

  • University of Colorado Hospital /ID# 245087

    Aurora, Colorado, 80045

  • Tekton Research, Inc. /ID# 224411

    Austin, Texas, 78745

  • Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 227828

    Aventura, Florida, 33180

  • Wallace Rheumatic Studies Center, LLC /ID# 224374

    Beverly Hills, California, 90211

  • Beth Israel Deaconess Medical Center /ID# 222505

    Boston, Massachusetts, 02215-5400

  • Qualmedica Research, LLC /ID# 227817

    Evansville, Indiana, 47714-0805

  • Accurate Clinical Management /ID# 225509

    Houston, Texas, 77084

  • June DO, PC /ID# 221841

    Lansing, Michigan, 48911

  • Deerbrook Medical Associates /ID# 227330

    Libertyville, Illinois, 60048

  • Valerius Medical Group & Research Center /ID# 223922

    Los Alamitos, California, 90720-5402

  • Dr. Ramesh Gupta /ID# 225524

    Memphis, Tennessee, 38119

  • SW Rheumatology Res. LLC /ID# 225485

    Mesquite, Texas, 75150

  • Duplicate_NYU Langone Health/NYU School of Medicine /ID# 245088

    New York, New York, 10016-2772

  • Millennium Research /ID# 233192

    Ormond Beach, Florida, 32174

  • Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 227833

    Phoenix, Arizona, 85032-9306

  • Allegheny Health Network Research Institute /ID# 245086

    Pittsburgh, Pennsylvania, 15224

  • IRIS Research and Development, LLC /ID# 227814

    Plantation, Florida, 33324

  • Carilion Clinic /ID# 227832

    Roanoke, Virginia, 24016

  • East Bay Rheumatology Medical /ID# 225493

    San Leandro, California, 94578

  • STAT Research, Inc. /ID# 221840

    Vandalia, Ohio, 45377-9464

  • The Center for Rheumatology and Bone Research /ID# 225479

    Wheaton, Maryland, 20902

Other trials in United States

Japan10 sites

  • National Hospital Organization Asahikawa Medical Center /ID# 222394

    Asahikawa-shi, Hokkaido, 070-8644

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 222393

    Hiroshima, Hiroshima, 730-8619

  • EIRAKU Internal Medicine Clinic /ID# 222385

    Kagoshima, Kagoshima-ken, 890-0063

  • Saitama Medical Center /ID# 222389

    Kawagoe-shi, Saitama, 350-8550

  • Hospital of the University of Occupational and Environmental Health, Japan /ID# 222499

    Kitakyushu-shi, Fukuoka, 807-8556

  • Shinshu University Hospital /ID# 222395

    Matsumoto-shi, Nagano, 390-8621

  • Chukyo Hospital /ID# 223398

    Nagoya, Aichi-ken, 457-8510

  • NHO Nagoya Medical Center /ID# 222397

    Nagoya, Aichi-ken, 460-0001

  • Tohoku University Hospital /ID# 222392

    Sendai, Miyagi, 9808574

  • Keio University Hospital /ID# 222498

    Shinjuku-ku, Tokyo, 160-8582

Other trials in Japan

Spain8 sites

  • Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 221993

    A Coruña, 15006

  • Hospital Universitario Basurto /ID# 221999

    Bilbao, Vizcaya, 48013

  • Hospital Universitario de Galdakao /ID# 221996

    Galdakao, Vizcaya, 48960

  • Hospital Universitario 12 de Octubre /ID# 221994

    Madrid, 28041

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 221995

    Sabadell, Barcelona, 08208

  • Hospital Universitario Virgen de Valme /ID# 221997

    Seville, 41014

  • Hospital Universitario y Politecnico La Fe /ID# 221998

    Valencia, 46026

  • HUA - Txagorritxu /ID# 221992

    Vitoria-Gasteiz, Alava, 01009

Other trials in Spain

Argentina7 sites

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 222569

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1426

  • Aprillus Asistencia e Investigacion /ID# 221890

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1958

  • Hospital Interzonal General de Agudos General Jose de San Martin /ID# 221893

    La Plata, Buenos Aires, 1900

  • CER Instituto Medico /ID# 223175

    Quilmes, Buenos Aires, 1878

  • Instituto CAICI S.R.L /ID# 221892

    Rosario, Santa Fe Province, 2000

  • Centro de Investigaciones Medicas Tucuman /ID# 221888

    San Miguel de Tucumán, Tucumán Province, 4000

  • Investigaciones Clinicas Tucuman /ID# 221889

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Mexico6 sites

  • Centro Integral en Reumatologia S.A de C.V /ID# 221914

    Guadalajara, Jalisco, 44160

  • Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 221910

    Guadalajara, Jalisco, 44690

  • Morales Vargas Centro de Investigacion S.C. /ID# 221912

    León, Guanajuato, 37000

  • Medical Care & Research SA de CV /ID# 221911

    Mérida, Yucatán, 97070

  • RM Pharma Specialists S.A de C.V. /ID# 221915

    Mexico City, Mexico City, 03100

  • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 221913

    Mexico City, Mexico City, 11850

Other trials in Mexico

Taiwan6 sites

  • Taichung Veterans General Hospital /ID# 221748

    Taichung, Keelung, 40705

  • China Medical University Hospital /ID# 221747

    Taichung, 40447

  • Taipei Veterans General Hosp /ID# 221746

    Taipei, Keelung, 11217

  • Taipei Medical University Hospital /ID# 227653

    Taipei, 11031

  • National Taiwan University Hospital /ID# 221745

    Taipei City, Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 222469

    Taoyuan City, 333

Other trials in Taiwan

Colombia5 sites

  • Duplicate_Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 221879

    Barranquilla, Atlántico, 80002

  • Duplicate_Centro de Investigacion en Reumatologia y Especialidades Medicas- CIRE /ID# 221884

    Bogota, Cundinamarca, 110221

  • Preventive Care Sas /Id# 221881

    Chía, Cundinamarca, 250001

  • Clinica Universitaria Bolivari /ID# 221880

    Medellin, Valle del Cauca Department, 050034

  • Healthy Medical Center S.A.S /ID# 221882

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

China4 sites

  • Duplicate_Peking Union Medical College Hospital /ID# 222950

    Beijing, Beijing Municipality, 100730

  • Guangdong Provincial People's Hospital /ID# 222851

    Guangzhou, Guangdong, 510080

  • Huashan Hospital, Fudan University /ID# 222929

    Shanghai, Shanghai Municipality, 200040

  • People's Hospital of Xinjiang /ID# 222928

    Urumqi, Guizhou, 830001

Other trials in China

Poland4 sites

  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 224430

    Krakow, Lesser Poland Voivodeship, 31-011

  • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 221859

    Poznan, Greater Poland Voivodeship, 61-545

  • MTZ Clinical Research Powered by Pratia /ID# 224431

    Warsaw, Masovian Voivodeship, 02-172

  • WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 221860

    Wroclaw, Lower Silesian Voivodeship, 51-685

Other trials in Poland

Australia3 sites

  • Emeritus Research /ID# 223027

    Camberwell, Victoria, 3124

  • Monash Medical Centre /ID# 221814

    Clayton, Victoria, 3168

  • Rheumatology Research Unit Sunshine Coast /ID# 221816

    Maroochydore, Queensland, 4558

Other trials in Australia

Bulgaria2 sites

  • UMHAT Sveti Ivan Rilski /ID# 223358

    Sofia, 1431

  • UMHAT Sveti Ivan Rilski /ID# 223359

    Sofia, 1431

Other trials in Bulgaria

Germany2 sites

  • Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 222963

    Berlin, 10117

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 222964

    Dresden, 01307

Other trials in Germany

Hungary2 sites

  • Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 222480

    Debrecen, Hajdú-Bihar, 4032

  • Vital Medicina Kft /ID# 222479

    Veszprém, Veszprém megye, 8200

Other trials in Hungary

Puerto Rico2 sites

  • GCM Medical Group PSC /ID# 224394

    San Juan, 00917-3104

  • Mindful Medical Research /ID# 222513

    San Juan, 00918-3756

Other trials in Puerto Rico

United Kingdom2 sites

  • Guys and St Thomas NHS Foundation Trust /ID# 221863

    London, London, City of, SE1 9RT

  • Duplicate_Manchester University NHS Foundation Trust /ID# 221861

    Manchester, M13 9WL

Other trials in United Kingdom

Italy1 site

  • Duplicate_Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 221919

    Cona, Ferrara, 44124

Other trials in Italy

New Zealand1 site

  • North Shore Hospital /ID# 221850

    Takapuna, Auckland, 0622

Other trials in New Zealand

South Korea1 site

  • Seoul National University Hospital /ID# 221897

    Seoul, Seoul Teugbyeolsi, 03080

Other trials in South Korea

About this study

Official title: A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms.

ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 100 sites worldwide.

Read more

Participants will receive the following for up to 56 weeks:

Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study.

Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B

There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Being tested
Elsubrutinib, Placebo for Elsubrutinib, Upadacitinib, Placebo for Upadacitinib
Keywords
Systemic Lupus Erythematosus, ABBV-599, ABBV-105, ABT-494, Elsubrutinib, Upadacitinib
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElsubrutinibDrug

    Also called ABBV-105

    Capsule; Oral

  • Placebo for ElsubrutinibDrug

    Capsule; Oral

  • UpadacitinibDrug

    Also called ABT-494, RINVOQ

    Film-coated tablet; Oral

  • Placebo for UpadacitinibDrug

    Film-coated tablet; Oral

Study groups in NCT04451772
Study groupRoleWhat they receive
ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) -> ABBV-599 High DoseExperimentalParticipants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
Receives: Drug: Elsubrutinib; Drug: Upadacitinib
Elsubrutinib placebo/upadacitinib 30 mg -> Elsubrutinib placebo/upadacitinib 30 mgExperimentalParticipants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
Receives: Drug: Placebo for Elsubrutinib; Drug: Upadacitinib
Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 High DoseExperimentalParticipants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.
Receives: Drug: Elsubrutinib; Drug: Upadacitinib
ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg) -> ABBV-599 Low DoseExperimentalParticipants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
Receives: Drug: Elsubrutinib; Drug: Upadacitinib
Elsubrutinib 60 mg/upadacitinib placebo -> Elsubrutinib 60 mg/upadacitinib placeboExperimentalParticipants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.
Receives: Drug: Elsubrutinib; Drug: Placebo for Upadacitinib
Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 Low DoseExperimentalParticipants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.
Receives: Drug: Elsubrutinib; Drug: Upadacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Emergent Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as an adverse event with an onset date that is on or after the first dose of study drug from Study M20-186, and no more than 30 days after the last dose of study drug from Study M20-186. For more details on adverse events please see the Adverse Event section.

    Measured: From the first dose of study drug in Study M20-186 up to 30 days after the last dose of study drug, up to 442 days

Secondary outcomes (4)

  1. Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4

    SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline in Study M19-130:

    • ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
    • No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA])
    • No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.

    Measured: Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104

  2. Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response

    BICLA is a composite responder index. Achievement of BICLA response is defined as improvement in all initial A and B BILAG scores, with no more than one new BILAG B score without worsening of the overall condition (no worsening in Physician's Global Assessment [PhGA], < 0.3 point increase) and no worsening of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.

    Measured: Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104

  3. Change From Baseline in Daily Prednisone Dose Over Time

    Participants'current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented.

    Measured: Baseline of M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104

  4. Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) Flare Index Through Week 104

    The SELENA SLEDAI flare index defines mild/moderate or severe SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.

    Measured: From Week 56 through Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start27 Jul 2020
  3. Primary completion3 Jan 2024
  4. Study completion3 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04451772
Sponsor's protocol ID
M20-186
Other IDs
2020-001690-72
Status last verified
Dec 2024
First submitted
29 Jun 2020
Last updated
14 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elsubrutinib and Upadacitinib in people with Systemic Lupus Erythematosus (SLE), run by AbbVie at 87 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Japan, Spain, Argentina, Mexico and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (time frame: From the first dose of study drug in Study M20-186 up to 30 days after the last dose of study drug, up to 442 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04451772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.

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